Sunday, August 24, 2014

Oh, patents! Z-Mapp

Copyright © Françoise Herrmann

According to the WHO (World Health Organization) Ebola virus disease Updates in West Africa, 
“Between Aug, 19 and Aug. 20, 2014, a total of 142 new cases of Ebola virus disease (laboratory-confirmed, probable and suspected) and 77 deaths were reported from Guinea, Liberia, Nigeria and Sierra Leone” (WHO1 – GAR1). 

As of Aug 20, 2014, according to the same WHO Global Alert and Response (GAR) page, there were 1427 deaths and 2617 cases reported. Ebola virus has a case fatality rate of up to 90%. It is one of the world’s most virulent diseases. The current survival rate in this epidemic is 47%. (WHO2-GAR)

The question that arises almost immediately is whether there is a cure for this deadly disease, and/or for preventing it from spreading any further, both locally in the villages or crowded cities of the infected areas, and internationally across borders and continents -- to Europe and the rest of the world.  Indeed the extraordinary measures of isolation that were taken to bring home for treatment two infected American missionaries,  Dr Kent Brantly and Nancy Writebol, who both survived the disease, serve to further highlight the issue of treatment and access to it.

The usual scenario in connection to patented drugs and access to treatment is one of prohibitive costs, and the monopolies associated with the marketing and production of the drugs. For example, this is the well documented case of antiretroviral drugs for the treatment of Aids (Chneiweiss, 2013).  However, the availability of treatment for Edola virus disease is different in important ways that highlight a different set of ethical issues in the access to patented treatments.

The issue here pertains to a patented drug referred to as Z-Mapp, which is still in the pre-clinical stages of testing. This means that the drug, developed by Mapp Biopharmaceuticals Inc., with the support of the United States government (CDC and DoD), has only been tested in the laboratory, on animals or in test tubes, and has not yet completed the full cycle of clinical testing with humans required for assessing safety and effectiveness of the drug. A process required prior to obtaining authorization to market a drug, and specified in the provisions of US Federal Regulations Title 45, Part 46 on The Protection of human subjects, or equivalent European legislation, such as for example, France’s Code de la Santé Publique, Livre 1er, Titre II pertaining to biomedical research.,  

Who cares?  What other options beyond the miraculous are there for those people infected with the Ebola virus? If the two US missionaries survived the Ebola virus infection to return home to their families, virus free, after treatment with this experimental Z-Mapp drug, then this is already human cllinical testing with grand scale control…Well, that’s the gist of it, minus  roll-out issues. [CDC –Ebola Hemorrhagic Fever]

 Indeed the decision to make this Investigational New  Drug (IND) available under specific conditions within the context of this Ebola outbreak was unanimously approved by the WHO on August 11, 2014 [WHO3- Ethical Committee Report]. So that in a rare, and perhaps ground-breaking instance, communication finally completed in real time, between all the parties involved in the process of developing the drugs and those subjects and patients, for whom the drugs are intended in the first place – our not-so-distant neighbors in a globally connected world --infected with the Ebola virus.

Z-Mapp is patented in US2013149300 titled MONOCLONAL ANTIBODIES WITH ALTERED AFFINITIES FOR HUMAN FCyRI, FCyRIIIa, AND C1q PROTEINS. According to the patent 
specifications, the drug is designed for: 
" the prevention or treatment of human diseases including but not limited to infectious diseases (including Respiratory Syncytial virus, Ebola virus, Influenza virus), cancer (including breast cancer and B cell lymphoma) and inflammatory diseases (including rheumatoid arthritis and Alzheimer's)."
The abstract for Z-Mapp patent US2013149300 is included below as well as an image of this dreadful virus.
Disclosed herein are GNGN and G1/G2 antibodies that recognize and bind various FcRs and C1q. Also disclosed herein are glycan-optiminzed antibodies, predominantly of the GNGN or G1/G2 glycoform, with enhanced Fcgamma receptor binding achieved through CHO, Nicotiana benthamiana and yeast manufacturing systems. Nucleic acids encoding these antibodies, as well as expression vectors and host cells including these nucleic acids are also disclosed herein. Methods and pharmaceutical compositions including the monoclonal antibodies are provided herein for the prevention and/or therapeutic treatment of viral infections, cancers and inflammatory diseases.

WHO 1– Global Alert and Response (GAR) – Ebola Virus disease updates – West Africa
WHO 2- Global Alert and Response  (GAR) – Ebola virus disease
Chneiweiss, H. (2003) Sur les rivages de la misère : Épisode 1 : Le marché des médicaments essentiels. M/S – Médecine Sciences,  vol 19(8&9), pp. 892-894.
WHO 3– Ethical considerations for the use of unregistered interventions for Ebola Virus disease
CDC – Ebola Hemorrhagic Fever
US Federal Regulations –Title 45 – Part 46 on the protection of human subjects
Code de la Santé Publique – Première Partie, Chapt. 1er, Titre II – Recherches biomédicales

Aug. 24, 2014 3:32 am - SFO CA 37.62 … 6.0 on the Richter magnitude scale and no stopping the earth from quaking

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